| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN68177645 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | BR3002 |
| Public title | A collaborative trial to evaluate the role of radiotherapy and adjuvant tamoxifen in the conservative management of clinical stage I and II breast cancer |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Breast |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histologically proven adenocarcinoma of breast
2. Tumour size <5 cm
3. No clinically palpable axillary nodes
4.. Have had an operation resulting in a cosmetically satisfactory breast
5. No evidence of systemic metastases
6. No previous treatment for a malignancy by radiotherapy or chemotherapy
7. Patients with Paget's disease of the nipple, bilateral breast cancer or lymphoedema of the breast are excluded
8. No previous or co-existing malignancies, except basal cell carcinoma of skin and in-situ carcinoma of cervix
9. Patients must be fit enough to receive any of the specified treatments |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Following surgery to remove the tumour patients are randomised into one of six treatment groups:
1. Group A: Tamoxifen daily for 2 years
2. Group B: Tamoxifen daily until recurrence
3. Group C: Short radiotherapy plus tamoxifen daily for 2 years
4. Group D: Short radiotherapy plus tamoxifen daily until recurrence
5. Group E: Long radiotherapy plus tamoxifen daily for 2 years
6. Group F: Long radiotherapy plus tamoxifen daily until recurrence
SYSTEMIC TREATMENT: Tamoxifen 20 mg daily to start immediately following surgery
POST-OPERATIVE RADIOTHERAPY:
Short Radiotherapy: 40 Gy in fifteen daily fractions given over 3 weeks with a supplementary boost to the local tumour site of 15 Gy in five daily fractions.
Long Radiotherapy: 50 Gy in twenty-five daily fractions given over 5 weeks with a supplementary boost to the local tumour site of 15 Gy in five daily fractions. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN68177645 |
| Date last extracted from ISRCTN register | 17/04/2008 |
